A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders

Psychiatric Disorder Clinical Trial

— GLMwPD  

Official title:

A Randomized Controlled Study of Conservative Treatment of Granulomatous Lobular Mastitis Combined With Psychiatric Disorders

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05395949
• Other study ID #: GLMwPD
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 30, 2027

Study information

• Verified date: May 2022
• Source: Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Granulomatous lobular mastitis (GLM) is a relatively rare chronic inflammatory disease of the breast in clinical practice. A small number of patients develop hyperprolactinemia during psychiatric drug treatment, and most of these patients are nulliparous. At present, there is no unified treatment mode at home and abroad, and surgery is generally the main treatment. GLM is a sterile inflammation, and glucocorticoids and methotrexate can effectively relieve clinical symptoms and even reach the standard of cure. In order to reduce the recurrence rate and protect the breast appearance as much as possible, we propose a conservative therapy. The purpose of this study was to compare this conservative therapy of granulomatous lobular mastitis with existing surgical treatment, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients with psychiatric disorders .

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: January 30, 2027
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients aged 18 years or older with granulomatous lobular mastitis
• Patients with Psychiatric Disorders;
• Patients volunteered to participate in the study after informed consent.

Exclusion Criteria:

• Patients were diagnosed with mastitis with other definite etiology confirmed by pathology
• Patients in acute exacerbation of mental illness

Related Conditions & MeSH terms

• Breast Diseases
• Disease
• Granulomatous Mastitis
• Mastitis
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Drug:
• conservative treatment
Prednisone 30 mg/day, supplemented with calcium and omeprazole, and Prednisone were slowly reduced to 10 mg/day after symptoms were relieved, and combined with 7.5 mg/week MTX therapy.

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate	Inflammatory changes, mass, abscess or fistula formation, nodular erythema of the upper and lower extremities and joint pain occurred in the ipilateral breast within one year after surgery was defined as recurrence.	Up to 1 years
Primary	Breast appearance and cosmetic effect score	Refer to Harris standard to evaluate postoperative cosmetic effect. Specify the breast appearance and cosmetic effect rating table.	Up to 1 years
Secondary	recovery time	the timing of the disappearance of the symptoms including Inflammatory changes, mass, abscess or fistula formation, nodular erythema of the upper and lower extremities and joint pain occurred in the ipilateral breast	Up to 2 years